Kornimate/medical-research-clean huggingface dataset:
preliminary evaluation of castle barrier prototype uk

Conditions: Peristomal Skin Complication

Summary: the purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (castle) in a small population of subjects with irritated peristomal skin.

this is a single-site, unblinded, historically controlled, first use in humans study of a stoma barrier with a new formulation. approximately 34 subjects who are currently using a 2-piece tape bordered product and able and willing to wear a product will be enrolled. each participant is provided with one box containing 20 of the test barriers to be used consecutively according to their normal routine. each participant is also provided with a box containing 30 pouches selected to most closely resemble their current product. participants are asked to record the time of application and time of removal of each test barrier and their assessment of relevant characteristics for each test barrier. a clinical evaluation of the peristomal skin is conducted at study entry, at approximately mid way through the study and again at its conclusion. photographs are taken of the peristomal skin at each visit using a digital camera. individual participation in terms of wearing the barrier is for 30 days or until the test barrier has been used up, whichever comes first. the study is comprised of 3 visits, an enrolment visit, a mid-study visit and a completion visit and a phone call at approximately day 7.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * has colostomy or ileostomy * current uses two piece tape bordered barrier * has mild to moderate peristomal skin irritation * cares for their stoma independently in the community * at least 3 months post-operative * provides informed consent exclusion criteria: * has fistula on or near stoma * has been involved in stoma care study in the last 30 days * is pregnant or lactating (determined by interview only) * has existing medical condition that would compromise their participation or follow-up * currently uses convex ostomy products, paste and/or rings * is allergic to test barrier components * is undergoing chemo- or radiotherapy that may affect the interpretation of the results

Keywords: colostomy ileostomy irritant dermatitis two piece barrier
china post-marketing surveillance (pms) study of fabrazyme®

Conditions: Fabry Disease

Summary: this is a 54-week phase 4, open label, single arm study to evaluate the safety and the efficacy of fabrazyme (agalsidase beta) as enzyme replacement therapy (ert) in chinese participants with fabry disease.

study participation for each patient will be total of 54 weeks which will include 4 weeks of screening, 48 weeks of treatment period and 2 weeks of post study treatment observation

Eligibility criteria:
inclusion criteria: * participant must be 8 years of age or older, at the time of signing the informed consent * participants naive to agalsidase beta and agalsidase alpha * chinese participants diagnosed with fabry disease and with documented plasma or leukocyte αgal activity deficient below laboratory's reference range, and/or documented diagnosis by genotyping * participants must have one or more symptoms and signs consistent with manifestations of fabry disease (not limited to neuropathic pain, chronic kidney disease, hypertrophic cardiomyopathy, cardiac rhythm disturbances, cerebrovascular involvement, cornea verticillata, angiokeratoma, gastrointestinal symptoms, hypo- or anhydrosis) * a female participant is eligible to participate if she is not pregnant or breastfeeding and use an acceptable contraceptive method * participants and/or participant's legal representative capable of giving signed informed consent. exclusion criteria: * the participant has undergone kidney transplantation. * the participant has a clinically significant organic disease (with the exception of symptoms relating to fabry disease) in the opinion of the investigator, would preclude participation in the trial. * received an investigational drug, or device, other than fabrazyme, within 30 days of anticipated imps administration or 5 half-lives of the previous investigational drug, whichever is longer. * the patient has current evidence of kidney failure or renal insufficiency, as defined by egfr \<30 ml/min/1.73 m2. * individuals who have life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients included. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
radiomic analysis for predicting treatment response and clinical outcomes in malignancies

Conditions: Breast Cancer; Head and Neck Cancer; Brain Cancer; Gynecologic Cancer

Summary: in this study, the investigators aim to undertake a retrospective analysis of ct and mri scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.

imaging in oncology has widespread application with modalities like ultrasound, computed tomography (ct), magnetic resonance imaging (mri), positron emission tomography (pet) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. with the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. in this study, the investigators aim at developing ct and mri radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.

Eligibility criteria:
inclusion criteria: * breast, head and neck, brain, and gynecological malignancies * treated with radiation at odette cancer centre between 2010 and 2019 exclusion criteria: * n/a
radiation therapy for heterotopic ossification prophylaxis acutely after elbow trauma

Conditions: Elbow Fracture

Summary: the investigators hypothesized that radiation therapy could be safely administered acutely after elbow trauma, and it would decrease the number of patients that would require surgical excision of heterotopic ossification.

a multi-institutional, prospective randomized clinical trial will be employed to determine if single dose, limited field radiation therapy (xrt) will prevent post-traumatic heterotopic ossification (ho) after open reduction internal fixation of intra-articular distal humerus fractures and fracture-dislocations of the elbow and to assess function of the elbow after xrt and no xrt. patients will be randomly assigned to one of the two groups(xrt/treatment or no xrt/control) by a computer-generated randomization schedule. assignment will be in a ratio of 1:1 in a complete block design of 10. each clinical site will be provided with a separate randomization assignment for each study participant. the treating surgeon and patient will be blinded to group assignment until after operative treatment. clinical and radiographic assessments at 6 weeks, 3 months and 6 months post-operatively will be performed. the primary clinical outcome will be the mayo elbow performance score which measures pain, stability, function and motion. motion parameters (flexion, extension, pronation and supination) will be performed at each data collection point. primary radiographic outcome will be the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes at 6 weeks, 3 months, and 6 months post-operatively. further imaging (radiograph or ct) will be obtained past the 6-month interval if deemed necessary by the treating physician,or if fracture union was not achieved at 6 months. the presence of ho will be quantified by radiograph. all adverse events will be documented. the trial will be monitored periodically by the safety monitor at least twice a year to ensure protocol compliance and address safety issues.

Eligibility criteria:
inclusion criteria: * skeletally mature patients with minimum age of 18 years and maximum age of 65. * patients deemed appropriate for operative intervention by the treating physician. * distal humerus intra-articular fractures (types 13-c1, c2, and c3), with or without proximal radius/ulna fractures - open or closed. * fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed. exclusion criteria: * head injury, quantified by glasgow coma score (gcs) \< 13 at time of consent for operative intervention. * burns \> 20% total body area (tba) or involving the operative site. * patients with spinal cord injury affecting the upper extremities will be excluded. * open fractures which cannot be closed primarily within 72 hours of initial operative intervention. * patients with estimated life expectancy of less than one year due to preexisting condition.

Keywords: heterotopic ossification distal humerus fracture-dislocations of the elbow radiation therapy
breathing disorders in patients with congestive heart failure

Conditions: Congestive Heart Failure

Summary: the investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable congestive heart failure. the presence of sleep disordered breathing (sdb) and cheyne-stokes respiration (csr) while awake were investigated by overnight polysomnography. males and females were similar in age, body mass index, and lvef. prevalence of sdb was higher in males than females. during follow up of 25±10 months, 27% of the population died. nonsurvivors had lower lvef (p=0.01), worse nyha class (p=0.03) a higher proportion of csr-awake (p\<0.001) than survivors.

bakground: there is little information in sleep disordered breathing (sdb) in women with congestive heart failure (chf). we studied consecutive chf patients in order to compare sdb characteristics according to gender, and to determine overall mortality impact of sdb and cheyne-stokes respiration (csr) while awake. methods: eighty nine consecutive outpatients (29 female) with stable chf (lvef\<45%) were prospectively evaluated. the presence of sdb, as characterized by obstructive sleep apnea (osa) and csr during sleep, as well as csr while awake before sleep onset, were investigated by overnight polysomnography.

Eligibility criteria:
inclusion criteria: * patients with resting left ventricular ejection fraction (lvef) of less than 45% as determined by echocardiography; * stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation. exclusion criteria: * patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.

Keywords: sleep apnea cheyne-stokes respiration congestive heart failure
correlation between plasma oxidized low density lipoprotein levels and postoperative delirium

Conditions: Postoperative Delirium

Summary: postoperative delirium (pod) refers to an acute neurocognitive disorder that occurs within 1 week after surgery or before discharge. old age is one of the important risk factors for postoperative delirium. the incidence rate of the elderly is high, and the life span of human beings is increasing. postoperative delirium has adverse effects on both short-term and long-term outcomes, including mortality, ability to work, and dependence on society. low-density lipoprotein (ldl) is a key molecule in the cholesterol transport mechanism and is easily oxidized to oxidized low-density lipoprotein (oxldl). oxidized low density lipoproteins are immunogenic and are also cytotoxic to endothelial cells. some studies have shown that increased oxidative stress is one of the earliest changes in disease, and similar signs can be detected in patients with alzheimer's disease (ad) and mild cognitive impairment (mci), such as protein oxidation and lipids. an increase in the quality of the peroxidation index. for the study of anesthesiology, oxidative stress theory has long been recognized as one of the mechanisms of postoperative delirium. we have a hypothesis that plasma oxidized low-density lipoprotein levels are associated with postoperative delirium and can be used as an early warning marker for disease occurrence. based on clinical research data, we conducted a prospective cohort study to explore the correlation between plasma oxidized low-density lipoprotein levels and postoperative sputum, providing clinical prediction and diagnostic value.


Eligibility criteria:
inclusion criteria: * surgical treatment was performed in our hospital under standard anesthesia. * patients in orthopedics, urology and general surgery. exclusion criteria: * patients with mental illness or taking psychotropic substances before surgery. * preoperative dementia or cognitive dysfunction. * unable to communicate and cooperate with patients due to coma, language barrier or end-stage disease before surgery. * asa greater or equal to 4. * patients who have undergone neurosurgery and cardiac vascular surgery.

Keywords: postoperative delirium
a study of rocbrutinib in participants with relapse or refractory mantle cell lymphoma

Conditions: Mantle Cell Lymphoma (MCL)

Summary: this is an open-label, single arm, multi-center phase 2 study of oral rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to bruton's tyrosine kinase (btk) inhibitor.


Eligibility criteria:
inclusion criteria: 1. per 2017 revised who lymphoma classification criteria, subject must have diagnosed with mcl. 2. at least one measurable lesion. 3. subjects who have previously received the treatment regimen containing anti-cd20 and at least one btki treatment failed or relapsed after remission or intolerated; or subjects who have previously received btk inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-cd20. 4. ecog≤2. 5. adequate hematologic function. 6. adequate hepatic and renal function. 7. willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control. exclusion criteria: 1. received non-covalent btk inhibitor treatment. 2. subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of rocbrutinib: antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; any investigational treatment; patients who have undergone major surgery, severe trauma or radiotherapy. 3. subjects who have received the following treatments within 2 weeks before the first dose of rocbrutinib: steroids or traditional herbal medicine for antitumor purposes; strong and moderate cyp3a inhibitors and inducers; all drugs that may cause qtc interval prolongation or torsional tachycardia. 4. disease states where clinical manifestations may be difficult to control, including hiv, hbv, hcv, syphilis positive or active bacterial and fungal infections. 5. disease affects the central nervous system. 6. any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
gut microbiota in adults with chronic widespread pain

Conditions: Chronic Widespread Pain

Summary: we aim to identify the gut microbiome composition in adults with cwp. we will collect the stool sample of 120 healthy individuals and 120 chronic widespread pain patients. we hypothesize that the intestinal microbiota is altered in cwp compared to healthy subjects without cwp.

we aim to identify the variations in gut microbiota composition in hong kong adults with cwp. we hypothesize that the intestinal microbiota is altered in cwp compared to healthy control. the design of the study is a pilot case-control study with adults with cwp (n=120) and healthy adults without any chronic pain (n=120). participants will be recruited in 8 general-outpatient clinics in the new territories east region of hong kong.

Eligibility criteria:
inclusion criteria: 1. participants with chronic widespread pain participants will be asked, "in the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?", as a screening question for cwp. to meet the criteria for cwp, subjects have to report musculoskeletal pain in at least 4 of 5 body regions and in at least 3 or more body quadrants (as defined by upper-lower/left-right side of the body) and axial skeleton (neck, back, chest, and abdomen), with pain duration of more than 3 months. a widespread pain index (wpi) will be generated based on the number of pain sites. subgroup of patients with fibromyalgia will be identified according to the american college of rheumatology 2016 when subjects wpi of ≥ 7 and a symptom severity scale (sss) score of ≥ 5 or a wpi between 4 and 6 and an sss score of ≥ 9. 2. healthy participants healthy participants will be those without chronic pain and depression. a screening question 'in the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?' will be asked to determine whether participant has chronic pain. depression status will be determined by the questionnaire "patient health questionnaire-9" exclusion criteria: * participants with major chronic illnesses, such as malignancy, active inflammatory diseases, autoimmune diseases and metabolic diseases such as diabetes mellitus and thyroid diseases etc.; use of antibiotics, probiotics or prebiotics in the preceding 2 months, any acute illness in the preceding month, change in regularly taken medication in the preceding month, and substantial dietary alterations in the preceding month.
manual therapy and exercise in low back pain

Conditions: Low Back Pain

Summary: non-specific low back pain is one of the main causes of disability for health care worldwide. the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. moreover, can these techniques be combined?

non-specific low back pain is one of the main causes of disability for health care worldwide. nowadays, the mostly used technique to research low back muscular activity is electromyography. among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. the main objective that is aimed by this thesis, is the evaluation of muscular activation in the reduction of non-specific low back pain through a 12 weeks procedure programme, which includes therapeutic exercise combined with other treatment techniques, and assessing the psycho-social characteristics of pain. this study's population will be composed by at least 16 individuals per group, both male and female, with ages among 20 and 80. participants will be randomly and blindly divided in three groups of intervention. the three groups will be: the experimental group or exp group (all participants subject to therapeutic exercise), the experimental group, which will also be subject to manual therapy (mt group) and finally, the experimental group, which will also be subject to kinesio tape work (kt group).

Eligibility criteria:
inclusion criteria: * patients diagnosed with low back pain. * patients who are in stage 1 of the oswestry scale. * not receiving pharmacological treatment such as anti-inflammatories or corticosteroids * be able to understand the exercises and spanish language. exclusion criteria: * having any back surgery. * be taking any medication at the time of the study. * have a pathology in which exercise is contraindicated (spondylolisthesis, spondylolysis, spondyloarthrosis). * be in a state of gestation or if there is the possibility of being. * present or have presented some oncological process.

Keywords: chronic pain manipulation, musculoskeletal catastrophisation kinesiotaping exercise
raas inhibitor drugs in dialysis patients

Conditions: Hypertension; End Stage Renal Disease

Summary: hypertensive haemodialysis patients are at high risk for cardiovascular events. this study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stage 5 * undergoing maintenance haemodialysis for a minimum of 3 months * existing arterial hypertension or * history of arterial hypertension or * resting blood pressure ≥140/90 mmhg or * antihypertensive medication * man and female * 18 years and older. exclusion criteria: * recent myocardial infarction (less than 3 months) * atrial fibrillation/atrial flutter * hypotension with systolic blood pressure of \<90 mmhg * high-grade aortic stenosis * left ventricular ejection fration \<50% * known allergy to aliskiren * severe disorders of liver function
green light effects on anxiety

Conditions: Anxiety

Summary: the main goal of this study is to determine whether exposure to a narrow band of green light (nbgl) improves outcome of psychotherapy sessions for the treatment of anxiety. this is a within-subject study design that examines nbgl effects (as compared to white light) on anxiety level and treatment success, as evaluated by the treating psychotherapist and the patient. for each participant, the study will consist of 8 therapy sessions, each lasting 60 minutes, in which light conditions will be presented in the following order session 1: white light, session 2: white light, session 3: nbgl (i.e., green light), session 4: nbgl, session 5: nbgl, session 6: nbgl, session 7: white light, session 8: white light effects of lights (white vs.nbgl) on anxiety level will be evaluated at the beginning and end of each therapy session by the patient, using a validated questionnaire. at the end of each session, the treating psychotherapist will fill another evaluation form that summarizes her/his impression of the treatment success or lack of.

each patient is treated once a week and thus, study participation time is expected to last 8 weeks. patients will self evaluate their anxiety level at the beginning and end of each of the 8 therapy sessions by completing the 20-questions state-trait anxiety inventory (stai form y-1). therapists will fill the following form after each of the 8 sessions: did you feel any difference while working with the patient in the green light as compared to regular room light? check all that apply: * i was more focused * i was more relaxed * the patient was more relaxed * the patient was more engaged * the patient seemed more open * the therapy progressed further

Eligibility criteria:
inclusion criteria: * diagnosis of anxiety * being a patient at the delray center * older than 18 and younger than 95 * being able to communicate in english * willingness to sign informed consent exclusion criteria: * co-morbid psychiatric conditions